|
Device | PROPEL AND PROPEL MINI SINUS IMPLANT |
Generic Name | Drug-eluting sinus stent |
Applicant | INTERSECT ENT 1555 ADAMS DR MENLO PARK, CA 94025 |
PMA Number | P100044 |
Supplement Number | S022 |
Date Received | 06/16/2016 |
Decision Date | 07/25/2017 |
Product Code |
OWO |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for modification of the in-process drug coating weight specification from ± 5% to ± 7%. |